Pay for delay

Happy new year to all readers! May you stay safe and healthy and as free as possible (yes, this is a new 2021 addition relative to previous wishes).

This year starts off on this blog with a somewhat misleading post title. Nope, this post will not be about competition law and pharma patents. Actually it will be about having to pay when you delay court proceedings. Advisory note: there is a risk that only true procedural law afficionados may enjoy today’s decision.

Waff is a French company founded in 2001 and specialized in inflatable pillows for physiotherapy and fitness.

Waff owns a European patent No. EP 1262125 on such a pillow. Waff considers that gym pillows marketed by the well-known Decathlon retail stores infringe its patent. After the customary infringement seizure and other pre-litigation skirmishes, Waff filed an infringement action in August 2019 with what was still the Paris Tribunal de grande instance and is now the Tribunal judiciaire.

On January 16, 2020, Decathlon filed submissions on the merits, claiming first (in limine litis) that the complaint was invalid.

At this point of the narrative, the aforementioned procedural law afficionados have probably started twitching, and we will understand why in a minute. On September 10, 2020, Decathlon repeated that the complaint was invalid, but this time in a motion in front of the judge in charge of case management. Waff replied, and one week later, Decathlon changed its mind and withdrew its motion.

In her order dated November 20, 2020, the case management judge acknowledged that the procedural motion was withdrawn. However, a ruling still had to be issued as the infringement plaintiff had filed a cost counterclaim.

What happened, and why did Decathlon withdraw its motion? To answer this question we need to look at the Code de procédure civile.

According to article 74, procedural exceptions must be raised before any defense on the merits; if not they are held inadmissible. According to article 73, a procedural exception is a defense aiming at holding proceedings irregular or extinct, or at staying proceedings. The argument that the infringement complaint is invalid is therefore such a procedural exception.

In this case, Decathlon raised the exception together with its first submissions on the merits – presumably before the actual discussion on the merits, and thus in limine litis. So far so good. However, article 789 also specifies that the judge in charge of case management, once he/she has been designated, has exclusive jurisdiction to rule on a number of motions, including procedural exceptions.

Therefore, the complaint invalidity defense should have been filed in front of the case management judge, and not together with the submissions on the merits, which are filed in front of the court, not the judge in charge of case management. This defense was thus inadmissible. A few months later, it was filed again in front of the right judge, but too late, as the submissions on the merits had already been filed, so that this second submission was thus no longer in limine litis.

This is an illustration that French procedural law is full of traps and is extremely (probably excessively) formalistic. But that’s what it is.

As a side note, the law changed in January 2020. The judge in charge of case management now has broader jurisdiction, in particular over other procedural motions known as “fins de non-recevoir” (in connection with e.g. the statute of limitations or standing to sue).

Going back to our pillow case, so to speak, the complaint invalidity defense was inadmissible, and the judge made sure to note it in her ruling, even though the motion had been withdrawn. And she did not stop there. She also held that this defense was clearly without merit anyway:

[…] Decathlon cannot state that it was impossible for them to determine the object of the complaint and thus defend themselves, while filing submissions on the merits at the same time. Besides, the complaint was clearly directed to patent infringement by reproduction of all of the claims (a main independent claim and five dependent ones) of the EP’125 patent, which was unambiguously identified, as was the […] allegedly infringing pillow, both by its reference and by the bailiff’s reports and infringement seizure reports in annex. 

The court then deduced that Decathlon had “voluntarily delayed the proceedings“, and sentenced them to pay a civil fine of EUR. 3,000, in accordance with article 32-1 of the Code de procédure civile.

This provision is seldom used at least in patent litigation. It makes it possible for a judge or court to punish any party filing a claim in a dilatory or abusive manner by a civil fine of up to EUR. 10,000. The fine should be paid to the state, not the other party.

This is quite harsh as a matter of principle, even if the amount itself is not very significant in view of the usual cost of patent infringement proceedings.

I rest my case.

I suspect that it is the conjunction of the motion being held inadmissible, ill-founded, and ultimately withdrawn which led to this unusual order. If it had been admissible but ill-founded, I assume that it would have been rejected without any civil fine. Unless this is a deterrent that the current IP judges of the Paris Tribunal judiciaire intend to showcase in 2021?

By the way, many thanks to the reader who sent me this decision. I am looking forward to receiving more! As has been repeatedly pointed out and complained about, rulings from the Tribunal judiciaire have stopped being published for a very long time, so word of mouth is all we’ve got.

So here is (finally) a non-Covid-related wish for 2021: may all court rulings which are supposed to be public be actually made public again.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 3ème section, ordonnance du juge de la mise en état, November 20, 2020, SAS Waff v. Decathlon SE & Decathlon France SAS, RG No.19/10207.

Not a tough patent to crack

After electronic cigarettes in the latest post, I have decided to take this blog one giant step further today, by discussing a patent on… crack pipes.

There are three actors in this case.

First, Terpan is a company active in the field of STD prevention. Owing to a cooperation with seven associations in Paris, they designed a risk-reducing kit for crack cocaine users, called “Kit Base“. This kit can be employed by users to reduce the risk of blood-mediated HIV or hepatitis C infection.

Terpan filed a French patent No. FR 3002724 on this kit in February 2014 (claiming an internal priority of March 2013).

The second actor, Action Solidaire Développement (ASD) is a one-person business distributing risk-reducing kits to various associations.

Finally, SAFE is an association active with drug users. By the way, it is one of the seven associations that participated in the elaboration of the Kit Base with Terpan.

Until 2017, ASD and SAFE bought the Kit Base from Terpan. Then they stopped and started providing users with another kit (somewhat unsurprisingly called Kit Crack), which Terpan considers is an infringement of its patent. Terpan thus launched an infringement action in July 2017.

ASD and SAFE filed a nullity counterclaim.

The first ground of nullity addressed in the judgment is a rather exceptional one. The defendants argued that the invention was excluded from patentability because its commercial exploitation would be contrary to ordre public and morality.

Claim 1 of the patent is broadly directed to a “kit for consuming solid or semi-solid products by inhalation“. However, the court held that the context of the description makes it clear that the invention is specifically about drug (and more particularly crack cocaine) usage.

The defendants’ argument interestingly relied on an old judgment by the Tribunal civil de la Seine, in 1913, which held a patent on an opium pipe contrary to ordre public and morality. However, one century later, the Paris Tribunal judiciaire did not follow this case law.

The court noted that, although drug use is prohibited in France, a first law authorizing public health measures against drug addiction was enacted in 1970. More recent reforms in 2004 and 2018 strengthened this policy. And so there are in particular public centers dedicated to drug users, in which kits such as the patented one can be legally distributed. These kits may thus be viewed as tools of public health prevention, and they do not breach the ordre public requirement. The 1913 judgment is now outdated since this public health policy did not exist at that time.

The court then moved on to the second ground of nullity, namely lack of novelty over the public prior use of Terpan’s own Kit Base.

An effect of the Kit Base?

Remember that the FR’724 patent claims an internal French priority of March 4, 2013? Well, according to SAFE, Kit Base was marketed as from 2012. This was not challenged by Terpan. However, the patent proprietor stated that the kit was modified over time based on feedback from various associations so that there was no evidence that the kit in use in 2012 corresponded to the claimed invention.

The court was not persuaded by Terpan’s defense. The court took a body of evidence into account:

  • Terpan’s website mentions that the Kit Base “in its final version” has been available on the market since April 2012.
  • Terpan supplied one association in 2010-2011 with filters made of wire having exactly the dimensions and wire diameter specifications recited in dependent claims 2, 3, 6 and 7. The context makes it clear that these filters were intended to make drug usage kits.
  • In April 2012, Terpan supplied various drug risk reduction centers with the Kit Base, under a single common reference.
  • A Kit Base sample allegedly supplied to an association in 2012 was described in a bailiff’s report in 2017 as corresponding to the claimed invention.

Regarding this latter point, the court acknowledged that the evidence was not bullet-proof as the kit described in the report was not taken from an intact original package.

Nevertheless, overall, this body of evidence was sufficient to convince the court that the Kit Base marketed in the Spring of 2012 already contained the same elements as the current Kit Base which implements the FR’724 patent.

Therefore, all claims alleged to be infringed were held invalid as lacking novelty over Terpan’s own marketing of the Kit Base.

A few remarks on this finding, if I may.

The court seems to have applied some sort of balance of probabilities approach in appraising the available evidence.

This seems very reasonable. Since the alleged public prior use originated from the patent proprietor (and plaintiff) itself, said patent proprietor had (or should have had) all of the necessary evidence to counter the defendants’ allegations.

In particular, the proprietor’s contention that the Kit Base may have changed over time seems to be clearly lacking. Since the Kit Base is theirs, they should be able to precisely set out and prove which modifications were made and when. I often find it disheartening when a party makes a good prima facie infringement or invalidity case which is successfully brushed off by the other side simply because the burden of proof is completely one-sided. This was not the case here, and I think it is a sound approach.

Finally, the court made reference in its reasoning to article L. 611-13 Code de la propriété intellectuelle, which mirrors article 55 EPC and relates to non-prejudicial disclosures – and frankly I have no idea why.

The court noted that Kit Base was put on the market more than 6 months before the priority date of the patent at stake, “so that” the claims lack novelty. However, as far as I understand, there was no allegation that the disclosure was an evident abuse. In fact the disclosure was made by the proprietor itself, which seems to leave little room for a possible abuse argument. Therefore, and unless some points made by the parties are not properly reflected in the judgment, there was probably no reason whatsoever to refer to this 6-month period. Did I miss something, or are we talking about a French patent here and not a German utility model? Just to be clear, there is no grace period in this country.

The final part of the judgment relates to Terpan’s additional claim for unfair competition and commercial free-riding. Terpan reproached the defendants with copying features of its Kit Base.

Again, the court did not find in favor of the plaintiff.

First, Terpan’s alleged R&D investments were not proven, especially because the kit was the result of collective work together with various associations.

Second, the presentation similarities noted by Terpan between the defendants’ Kit Crack and the original Kit Base (presence of a soothing cream and of a kit assembling drawing) were said to relate to commonplace features; whereas, on the other hand, the court insisted on some significant differences between the two kits (such as the presence of an alcohol-imbibed pad, or different looking packages).

With a decision as interesting as this one, one could easily become addicted to case law.

PS: Many thanks to Jérôme Tassi for first drawing my attention to this decision!


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 3ème section, November 6, 2020, Terpan v. Action Solidaire développement & SAFE, RG No. 17/12393.

Seeing the patent half empty

As an introduction, I am pleased to pass on the announcement of the upcoming patent seminar of the Institut de Boufflers, which will take place next week – online as you may guess.

The program is here, it looks great as usual, and I personally will be honored to participate in a panel discussion on the second day of the seminar (Nov. 25), dedicated to the evolution of European patent law. See you there.

Moving on to today’s case law report, I rarely miss an opportunity to comment on a decision touching upon a serious point of insufficiency of disclosure.

As a matter of fact, this ground of nullity is so seldom successful that it suddenly becomes quite interesting when it is – especially in the non-medical arts.

Directbuy is a French company specialized in electronic cigarettes and related liquids and accessories. It is located in Heillecourt, Lorraine, 5527 inhabitants (says Wikipedia). It filed a French patent application in April 2015, which was granted on November 3, 2017 under number FR 3034627. The patent relates to a device for assembling an e-cigarette and filling it with liquid.

In January 2018, Directbuy initiated infringement proceedings based on this patent against LCCF Distribution, another company located in Saint Martial d’Albarède, population of 467, (yes, that would be more than 10 times fewer than Heillecourt) in Dordogne. What would I do without Wikipedia indeed.

LCCF Distribution filed a nullity counterclaim, raising several grounds of nullity.

Had they prevailed on their first ground of nullity, the decision of the Paris Tribunal judiciaire would have been even more remarkable – but they did not.

This first ground of nullity was indeed that the patent did not relate to an invention.

Here is claim 1 of the patent:

A device for assembling and filling a vial with liquid for an electronic cigarette comprising at least one means for filling said liquid to which means are connected for supplying this liquid, characterized in that said means for filling are connected to means for supplying at least two liquids of different compositions through selection means to select, under the impulse of appropriate control means, the distribution of a liquid or a mixture of liquid in varying proportions.

Liquid selecting means – so pre-Covid…

LCCF’s argument was that the claim merely recites results to be achieved and that the structural and functional means allowing to obtain these results were not disclosed. In other terms, only a technical problem was claimed.

As you can see, this argument already had a flavor of insufficiency of disclosure. It was squarely rejected by the court as follows:

It is recalled that, in order to determine whether a patent application relates to an invention falling within the scope of patents, it is necessary to examine the nature of the problem that the patent application proposes to solve and the solution it intends to provide therein. Patentability can relate only to solutions having a technical character, while an immediate technical result in the industrial field is necessary, even though this result is weak and of weak interest.

The patent in dispute, highlighting the shortcomings linked to the traditional method of making manual mixtures of liquid, sometimes dangerous for the user and with imprecise nicotine concentrations, intends to solve these difficulties by implementing a device for assembling and filling a liquid vial by methods providing for mechanical filling by means of supplying at least two different liquids through selection tools.

The patent, which does not simply describe results, therefore proposes a technical solution to solve a technical problem.

However, turning to the second ground of nullity, insufficiency, the court noted that the description of the patent was excessively empty:

The description is particularly limited as to the described device. It merely reproduces the wording of claim 1 of the patent to explain the only including figure which is extremely schematic.

No details are given on the nature of the filling means and the liquid supply means. The means of selection invoked are not described. No explanation is given on the means of calculating the nicotine concentration of the liquid mixture which are only mentioned.

The description does not include any embodiment of the invention which may clarify the claims. 

Consequently, the patent is not sufficiently described for a person skilled in the art to be able to implement the invention (with the sole assistance of the description and the drawing).

Therefore, the patent was revoked in its entirety, without examining the other grounds of nullity of lack of novelty and lack of inventive step.

I have had a look at the patent at stake, and it is true that the description is rather succinct. The description is only two and half pages long, of which one page is dedicated to the prior art. In the rest of the description, the various “means” recited in claim 1 and its two dependent claims are mentioned, but without much in terms of additional explanations.

In other words, the court’s analysis of the patent appears to be correct. What they did not address, though, is common general knowledge. Could it somehow make up for the shortcomings of the description?

That said, even if sufficiency had been acknowledged (taking into account common general knowledge), there may have been serious issues concerning novelty and inventive step as well – which may be why the court directly went for the jugular.

In fact, looking at the preliminary search report issued by the EPO (on behalf of the INPI), all three claims as filed were deemed to lack novelty over a D1 document and to lack inventive step over a D2 document combined with a D3 document.

In its response to the search report, the applicant did not amend the claims and argued thusly:

The prior art is analyzed as follows: 

Document D1 is an article published online and reviewing the state of the art in the field of electronic cigarettes and machines for filling vials with liquid for these cigarettes.

Document D1 does not disclose all the technical features recited in claim 1 of the invention. 

Document D2 is a patent application publication relating to a method for filling vials for electronic cigarettes and the related device .

Document D2 does not disclose all the technical features recited in claim 1 of the invention. 

Document D3 is a patent application publication describing a device for filling containers in the pharmaceutical field. 

Document D3 does not disclose all the technical features recited in claim 1 of the invention. 

These three documents are therefore not relevant for the appraisal of novelty. 

The applicant’s comments on inventive step were of the same nature. As a next step, the patent was granted.

As I am sure all readers are well aware, the French patent statute has been recently amended by the PACTE law. One major aspect of the reform was to strengthen examination of national patent applications in France. The patent at stake was granted under the former, pre-PACTE provisions, which, obviously, made it possible to obtain a patent without spending much effort on setting out why exactly the invention deserved one.

I have heard, and even expressed myself, concerns that the PACTE reform may hurt local applicants wary of the higher costs typically associated with more serious, EPO-type prosecution.

On the other hand, maybe today’s decision could be viewed as an example of why raising the bar, while not a perfect solution, was in fact necessary.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 1ère section, February 6, 2020, Directbuy v. LCCF Distribution, RG No.18/02372.

A man of two jobs

In today’s case, the facts and the timeline are everything, and they are far from straightforward, so bear with me.

  • Flex Elektrowerkzeuge (“Flex”) is a German company marketing electrical appliances and tools such as sanders.
  • In 1990 a French company called Flex Electroportatif Machines et Accessoires (“FEMA”) was set up to distribute Flex’ products in France.
  • In 1992, a Mr. B (remember his name! I mean, his initial) became the CEO of FEMA.
  • In 1995, Mr. B founded another company, Accessa.
  • In 1999, yet another company, MBH Développement (“MBH”) was founded by Mr. B and a Mrs. H.
  • In 2005, a first dispute arose between the German company Flex and Mr. B. Flex discovered the existence of MBH and learned that MBH had registered several trademarks (such as “Asflex”) covering products typically marketed by Flex. The dispute ended with a transaction signed in 2007, per which the trademarks at stake were assigned to Flex.
  • In 2007, Flex discovered that MBH had filed two patent applications on sanders, listing Mr. B as an inventor. Flex was again (unsurprisingly) quite unhappy. The matter was however resolved with MBH granting a free, exclusive license agreement to Flex in 2008. Another license agreement was executed between MBH and FEMA in 2009.
  • In 2011, Flex agreed to the acquisition by MBH of part of the shares of FEMA. Further to this acquisition, the major shareholders of FEMA were Flex and MBH.
  • In 2014, an exclusive distribution agreement was signed between FEMA and Accessa, while MBH took control of Accessa.
  • Later in the same year, Flex acquired most of the shares of FEMA, took full control of the subsidiary and replaced Mr. B as the CEO.
  • In 2016, FEMA filed a complaint against Mr. B, MBH and Accessa in front of the Paris TGI.
  • In 2018, both Accessa and MBH went into liquidation.
  • In November 2019, the Paris TGI issued its judgment.
  • MBH appealed and FEMA counter-appealed, which leads us to the appeal decision dated September 22, 2020 and discussed today.

The first instance lawsuit had several prongs: infringement and invalidity claims on the one hand, and an ownership claim on the other hand.

I have almost no information to share on the infringement and invalidity aspect, as this part was not challenged on appeal – and as the first instance judgment is not readily accessible online (yes, the outrageous unavailability of first instance judgments in France still persists to this day). I will thus focus on the ownership part of the litigation, which is addressed in the appeal ruling.

The dispute on appeal centered on a number of patents and patent applications filed from 2005 to 2014. Here is the full list: FR 3026668, FR 3025447, FR 3024063, FR 3021889, FR 2980502, FR 2980501, EP 2572828, EP 2314422, FR 2936439, EP 2113338, FR 2882913, EP 1632311, EP 1570932.

All of them, it seems, were filed by MBH, with Mr. B as the inventor. FEMA claimed full ownership of this portfolio.

The first instance judges granted this request, which is why MBH (or rather the administrator in charge of its liquidation) appealed.

The Cour d’appel essentially confirmed the first instance ruling. In its reasoning, the court relied on a whole body of evidence rather than a single fact.

First, they noted that FEMA had an R&D department, in which a Mr. B was employed – not the same Mr. B as defendant-Mr. B, mind you, but since the judgment has been extensively redacted, it is not always easy to get your bearings. This was evidenced, inter alia, by the employment agreement of this second Mr. B (shall we say Mr. B’?), an organization chart as well as industrial drawings (one of which was quite similar to the figure of one of the patents in suit).

Second, looking at MBH’s management reports, they were not persuaded that MBH had any actual R&D activity. As from 2008, the reports started mentioning an R&D activity justifying a tax rebate, but the court was of the opinion that this only corresponded to patent costs. An accounting report dated 2019 mentioned the existence of R&D costs and tools, but the court did not trust this report as it was issued by Mrs. H, who is none other than Mr. B’s former partner at MBH and who happens to be currently involved in another lawsuit against FEMA.

The court was thus convinced that the inventions can only have been developed using FEMA’s resources.

Mr. B appears to have been a man of two jobs. Or as we would say in French: he had a double hat.

The appellant emphasized that the mother company Flex was aware of the existence of MBH as well as of its patent filing activity as early as 2006. However, the court deemed that this did not amount to a consent to MBH’s filings.

The license agreements signed in 2008 and 2009 did not imply any consent to MBH’s filings either. Indeed, FEMA was headed by Mr. B at that time, and he thus signed the MBH / FEMA contract on behalf of both parties. As to the MBH / Flex contract, it was analyzed by the court as an attempt by MBH to avoid litigation. More importantly, the agreements only covered one patent filed in 2005, and cannot be interpreted as a consent by FEMA concerning the later filings that took place from 2008 to 2014.

The fact that MBH became a shareholder of FEMA in 2011 cannot be interpreted as proof of consent to the patent filings either.

Another interesting defense raised by MBH was that FEMA’s action was time-barred. As a reminder, the patents / applications were filed from 2005 to 2014. The first patent in the portfolio was granted in 2007, and FEMA filed its complaint only in 2016.

According to article L. 611-8 Code de la propriété intellectuelle, the limitation period applicable to claims for ownership is in principle five years from the grant of a patent. But, “in case of bad faith at the time of grant or acquisition of the right, the limitation period is five years from the expiry of the right“. Depending on which starting point is used (grant or expiry of the patent), FEMA’s action would be time-barred with respect to at least part of MBH’s portfolio.

The court analyzed Mr. B’s behavior and concluded that he acted in bad faith. Said the court, Mr. B consistently concealed his activities, as evidenced by the successive discovery by Flex of the existence of Mr. B’s other companies, of his trademarks filings, and then of his patent filings. He was thus dishonest with FEMA. The court went on to consider that Mr. B’s bad faith also meant that MBH acted in bad faith, since Mr. B was the CEO and almost sole owner of MBH.

Therefore, MBH’s defense based on the statute of limitations also failed.

The court further noted that, until 2014, Mr. B remained FEMA’s CEO, so that FEMA was in practice not able to file suit before his departure.

The court concluded:

Mr. B, owing to his position as CEO of FEMA, used the financial, material and human resources of this company to develop inventions for the company MBH Développement that he created and headed, although they should have benefited FEMA, which should have been their owner, since the inventions related to products within its business perimeter. Therefore, the appealed judgment must be confirmed in that the ownership of the following patents and patent applications to FEMA was ordered: [….]. 

The court also ordered that all agreements on the patents between MBH, Accessa and FEMA be canceled. Besides, since the transfer of ownership is ex tunc, MBH must pay back FEMA any money earned through the exploitation of the patents. The court awarded provisional damages of EUR. 100,000 and ordered the communication of accounting information to enable a full assessment of damages.

MBH argued that the costs of patent filing and prosecution should be deduced from the damages, based on the general provision on unjust enrichment (article 1303 Code civil). The court disagreed, since MBH acted for its own profit and can thus not benefit from the unjust enrichment provision.

FEMA further requested that Mr. B be held personally liable in addition to MBH. However, the court deemed that this claim was time-barred, since FEMA was aware of Mr. B’s actions as early as 2006 (more than three years before the writ of summons filed in 2016). At first sight, this may seem contradictory with the finding that the claim for ownership of the older patents / applications was not time-barred, but the difference seems to be that the statute of limitations for an ownership claim explicitly contains a provision extending the limitation period in case of bad faith.

So, why is this case unusual? Well, first off, I think everyone will agree that the facts appear to be quite colorful, to say the least. But maybe this is always so in an ownership dispute.

Other than that, I do find the court’s reasoning unorthodox, to some extent.

Let’s go back to article L. 611-8:

If an IP right was filed on an invention either stolen from the inventor or their beneficiary, or in breach of a statutory or contractual obligation, the harmed party may claim ownership of the application or of the granted right. 

As a basic principle, an invention belongs to the inventor or his/her beneficiary. In order to know to whom a patent portfolio should belong, we must thus in principle 1) determine who the inventors are for each invention, and 2) establish whether there is an entity that holds the rights on the invention as a result of employment agreements signed by the inventors or as a result of any other statutory or contractual obligation.

But the court did not carry out this analysis. Assuming that Mr. B was the true inventor of the inventions at stake (which the judgment does not say), it should be borne in mind that inventions made by the head of a company who is not an employee do not necessarily and automatically (i.e. by way of the patent statute itself) belong to the company. The same applies for instance to an intern, who is not an employee either. So, did FEMA hold the rights on Mr. B’s inventions by way of an employment agreement? If not, what is the exact statutory or contractual obligation assigning his (presumed) inventor’s rights to FEMA and which was breached?

The court broadly stated that “Mr. B, owing to his CEO position at FEMA, used the financial, material and human resources of this company to develop inventions”.  While this of course sounds wrong and actionable, I am not sure it is in itself sufficient to conclude that FEMA was the true owner of the inventions. In particular, financial and material resources do not characterize ownership, I would venture. Human resources are an entirely different story, but again this aspect is not really addressed in the decision.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, September 22, 2020, SAS MBH Développement et al. v. Flex Electroportatif Machines & Accessoires FEMA, RG No. 20/00471.

This is not a pipe

A regular patent law blogging activity comes with a number of serious pitfalls. Rambling may be one of them.

I hope readers will amicably warn me if this blog ever gets there – unless this point has already been reached?

A couple of weeks ago, when commenting on the recent pemetrexed decision of the Paris TJ, I lamented that French courts have a tendency to rely on the detailed choice of words in the description of a patent to draw dramatic conclusions concerning its scope of protection – either to restrict it or to broaden it beyond the literal wording of the claims.

I would like to continue this conversation today, but with a different perspective, namely an SPC angle; the case I would like to look at is the latest judgment in the Inegy® litigation (already reported on by others here and there).

Merck Sharp & Dohme Corp. (MSD) owns SPC No. FR05C0040 (FR’040) based on European patent EP 0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin”. The originator’s product has been marketed as Inegy®.

At least four different lawsuits have taken place in France concerning this SPC, some of which have already been mentioned on this blog:

  • One involving Biogaran. MSD’s request for preliminary injunction was rejected in April 2018, and this rejection was confirmed in June 2018 (see this post), the reasons being that the SPC appeared to be invalid.
  • One involving Mylan and one involving Sandoz, in parallel. Here, MSD surprisingly obtained a preliminary injunction in March 2019 (see this post). This was however overturned on appeal in February 2020 (see this post), as the SPC appeared to be invalid.
  • One involving Teva, not yet mentioned on this blog.

Teva launched a generic version of Inegy® in April 2018 and initiated nullity proceedings against EP’599 and the FR’040 SPC. What was still known as the Paris TGI at that time rejected Teva’s nullity claim in October 2018, on the merits this time. By the way, this could be why a preliminary injunction was initially ordered against Mylan and Sandoz in March 2019 although it had been previously denied with respect to Biogaran in April-June 2018 (this piece of the puzzle was missing the last time I wrote on this topic).

Today’s decision is the ruling by the Paris Cour d’appel on Teva’s appeal against the October 2018 judgment. The first instance judgment has now been overturned, and the Cour d’appel has declared the FR’040 SPC invalid – consistently with its previous rulings of June 2018 and February 2020, but this time on the merits.

In the decision, the court rejected Teva’s objections to the validity of the basic EP’599 patent, but entertained Teva’s claim that the SPC itself is invalid under articles 3(a) and 3(c) of the SPC regulation. The reasoning is mostly in line with the February 2020 ruling already discussed here, so I may as well be brief.

EP’599 specifically claims:

  • a very broad family of compounds in claim 1 (in the form of a Markush formula);
  • ezetimibe as a specific compound in dependent claim 8; and
  • a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of the above compounds, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).

As a reminder, the FR’040 SPC is directed to the combination of ezetimibe and simvastatin.

The test of article 3(a) of the SPC regulation is whether the product was protected by the basic patent; and the test of article 3(c) of the SPC regulation is whether the product protected by the basic patent had already been the subject of a certificate.

In this case, MSD had already obtained an earlier SPC (No. FR03C0028) for ezetimibe itself.

The court reviewed the relevant case law of the CJEU, placing special emphasis on Sanofi, also known under the name of the other party, Actavis (C-443/12). In that case, based on a same patent, Sanofi had obtained a first SPC on the drug irbesartan based on a first MA, and then a second SPC on the combination of the drug irbesartan with a diuretic substance, HCTZ, based on a second MA. The CJEU ruled that, in this case, the grant of the first (mono) SPC prevented the grant of the second (combo) SPC.

The court found that the facts of the present case are very close to those of Sanofi – which, I think, is quite convincing.

Merck countered that, in Sanofi, the second compound HCTZ was not explicitly recited, only the therapeutic class (diuretics) was. But the court cited paragraph 30 of Sanofi: “it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent“. The court deemed that this reasoning applies in the present case.

Merck relied on two more recent CJEU rulings, namely Gilead (C-121/17) and Royalty Pharma (C-650/17), but the court found that these concern different situations and are not applicable.

The court then investigated “whether, from the perspective of the skilled person, based on common general knowledge at the filing date of the basic patent, and in the light of the description used to interpret the claims, according to article 69 EPC and its interpretative protocol, the product of the combination of ezetimibe and simvastatin, which is the subject-matter of the second SPC, is a product different from ezetimibe alone, protected by the patent as such“.

The court then turned to the description of the patent. Here is the central part of the reasoning:

The description of the patent, which uses the singular form to designate the invention, and uses the formulation “in yet another aspect” to present the combination of a hydroxy-substituted azetidinone, which is the subject-matter of the invention, with a cholesterol biosynthesis inhibitor, indifferently refers for hydroxy-substituted azetidinones alone and for their combination with a cholesterol biosynthesis inhibitor, to an effect “for the treatment and prevention of atherosclerosis or for the reduction of plasma cholesterol levels” without any indication of the specific therapeutic effect that distinguishes the product composed of ezetimibe alone from that comprising the combination of ezetimibe and a cholesterol biosynthesis inhibitor such as simvastatin. Therefore, the skilled person, who was aware in the prior art of the possibility of combining two anticholesterolemic drugs having different mechanisms of action (paragraph 8 of the patent – an HMG CoA reductase inhibitor and a bile acid sequestrant), and who was familiar with statins, and in particular simvastatin, which have been commonly used since the late 1980s for the treatment of hypercholesterolemia, will not consider that the combination of ezetimibe with simvastatin, or with the 9 other active ingredients also covered by claim 17 (in particular atorvastatin, for which Merck, on the basis of the same reasoning, filed a third SPC on September 12, 2014), constitutes a distinct product protected by the basic patent as such.

The underlying idea is that there is only one invention in the patent, namely ezetimibe itself (or the other compounds of the same class). The combination of ezetimibe with another, well-known, anticholesterolemic drug, is not patentably distinct from that invention, I would say (using U.S. vocabulary).

The court’s conclusion, as far as it is based on a review of the therapeutic effect of the products at stake, and of the actual contribution of the basic patent to the art, seems to make a lot of sense.

There is one portion of the reasoning that I do not feel comfortable with, though, namely the first part of the paragraph, in which the court pays attention to the expressions “the invention” (singular) and “in another aspect” – which, to me, do not really mean anything one way or the other.

Every patent attorney, sometimes every firm, has their own drafting style. This should have no impact on the extent of monopoly granted to a patent proprietor.

Let’s take an example. Imagine that, in the EP’599 patent, the combination of ezetimibe with another anticholesterolemic drug had been presented as being “a second invention“, or “a number of further inventions“. Should this have made a difference? Of course not. Simply naming a product as a distinct invention does not make it so.

“This is not a pipe” – can words change reality?

My fear is that some patent owners may take advantage of the judges’ over-reliance on contingent aspects of the specification to unduly extend the scope of their legal monopoly. Conversely, some may be hurt by innocuous, if unfortunate, syntactic structures.

Going back to the judgment at hand, the court decided that the case was clear and that there wasn’t any need for a reference to the CJEU. The FR’040 SPC was thus formally revoked.

According to reports published on other blogs, this is not the end of the story yet, as a final appeal in front of the Cour de cassation is already pending, at least in connection with the refusal to grant a PI against other generic companies. Presumably, this judgment is also going to be appealed.

As a final note, this seems to be one of these instances of fragmented European landscape. The decision acknowledges that preliminary injunctions have been granted and sometimes confirmed on appeal in Norway, the Czech Republic, Portugal, Belgium and Austria; and have been rejected (with sometimes a confirmation on appeal) in the Netherlands, Germany and Spain.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, September 25, 2020, SAS Teva Santé et al. v. Merck Sharp & Dohme Corp., RG No.18/23642.